- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985580
Effects of Blueberry Juice Consumption on Cognitive Function in Healthy Older People
December 2, 2016 updated by: University of Exeter
Effects of Blueberry Juice Consumption on Brain Activation and Perfusion in Healthy Older People
Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective.
The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse.
We therefore investigated whether 12 weeks of blueberry concentrate supplementation improved cognitive function in healthy elderly via increased brain activation and perfusion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 60-80y
- Addenbrooke's Cognitive Examination III questionnaire > 88
- Consuming 5 or less portions of fruit per day
Exclusion Criteria:
Addenbrooke's Cognitive Examination III questionnaire < 88 Contraindications for MRI Consuming more than 5 portions of fruit per day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Blueberry
Blueberry concentrate consumed daily for 12 weeks.
|
|
Placebo Comparator: Placebo
Placebo concentrate consumed daily for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain perfusion
Time Frame: Change from baseline to 12 weeks dietary supplementation
|
MRI - arterial spin labelling
|
Change from baseline to 12 weeks dietary supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activation
Time Frame: Change from baseline to 12 weeks dietary supplementation
|
fMRI whilst performing modified Stroop task
|
Change from baseline to 12 weeks dietary supplementation
|
Cognitive function tests
Time Frame: Change from baseline to 12 weeks dietary supplementation
|
Cogstate battery of tests
|
Change from baseline to 12 weeks dietary supplementation
|
Blood biomarkers of inflammation
Time Frame: Change from baseline to 12 weeks dietary supplementation
|
CRP, IL6,
|
Change from baseline to 12 weeks dietary supplementation
|
Blood biomarkers of oxidative stress
Time Frame: Change from baseline to 12 weeks dietary supplementation
|
protein carbonyls, glutathione
|
Change from baseline to 12 weeks dietary supplementation
|
Blood biomarkers of neurogenesis
Time Frame: Change from baseline to 12 weeks dietary supplementation
|
BDNF
|
Change from baseline to 12 weeks dietary supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanna Bowtell, PhD, University of Exeter
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
September 13, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (Estimate)
December 7, 2016
Study Record Updates
Last Update Posted (Estimate)
December 7, 2016
Last Update Submitted That Met QC Criteria
December 2, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 1314/134617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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